Search results for "EMA"
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Host-Cell Protein Measurement and Control
The European Medicines Agency (EMA) guideline CPMP/BWP/382/97 states, “In summary, for HCP, whatever the product and production system, residual HCP have to be tested for on a routine basis”…“As such,…
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Vaccine Development and Production Challenges Manufacturers
In 2014, GSK filed for approval of its RTS,S vaccine by the European Medicines Agency (EMA) under an EMA assessment process that could support a recommendation by the World Health Organization for mar…
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Challenges and Trends in Biopharma Facility Design
…iences): Regulatory requirements are not changing--assurance of product quality and patient safety remain central, which can create challenges for modular manufacturing designs. Companies taking adva…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
The EMA mAb guideline also draws attention to a number of structural features including N- and C-termini (in particular pyroglutamic acid at the N-terminus and lysine at the C-terminus of the heavy ch…
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Top Process Development Trends for 2022 and a Look into 2023
The European Medicines Agency (EMA) was even more successful—approving a record 55 therapies. More than half of these approvals were for patients with rare diseases such as acid sphingomyelinase defic…
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Developing a Robust Bioprocess Using Mechanistic Models
Regulatory agencies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA) demand strict requirements on process characterization and validation studies and ask for a deep …
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Biosimilars provide a more affordable treatment option, and this is likely to become more relevant in the future as the affordability of these products remains critically poor in emerging and underdev…
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Leveraging Data for Better Biopharmaceutical Process Control
Organizational obstacles
BioPharm: What obstacles remain to greater use of advanced monitoring and control in biopharma?
Gouveia: Some of the obstacles are not technical at all, but organiz…
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Ensuring the Biological Integrity of Raw Materials
UV disinfection has some support from the EMA, which recommends it as one of two complementary virus reduction steps.
According to Sasges, combining inline UV disinfection with other barrier metho…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Although the same concerns for safety are ultimately expected to drive other cell-culture bioprocesses toward this goal, several challenges still remain, including for some of the most promising new o…